Alvotech Resubmits U.S. Marketing Applications for Simponi, Simponi Aria, and Eylea Biosimilars
Alvotech announced it has resubmitted applications to the U.S. Food and Drug Administration (FDA) for marketing authorization in the U.S. for biosimilars to Simponi, Simponi Aria, and Eylea.
Alvotech announced on June 4, 2026, that it has resubmitted U.S. marketing authorization applications to the Food and Drug Administration (FDA) for its proposed biosimilars to Simponi, Simponi Aria (AVT05), and Eylea 2 mg (AVT06).
Prior to the resubmissions, Alvotech submitted a detailed response to an FDA Post-Application Action Letter (PAAL) related to a facility inspection conducted last summer. The company has spent recent months strengthening various aspects of its internal quality and manufacturing systems. Alvotech has also responded to FDA comments received following a routine inspection of its cGMP manufacturing license in early May.
Alvotech is collaborating with Teva Pharmaceutical Industries Ltd. for the marketing and sale of AVT05 and AVT06 in the United States, with Alvotech responsible for development, marketing applications, and manufacturing. For AVT03, a proposed biosimilar to Prolia and Xgeva (denosumab), Dr. Reddy's Laboratories Ltd. is the applicant seeking U.S. marketing authorization.
"These resubmissions mark a significant milestone following extensive work on our manufacturing and quality platforms," said Alvotech CEO Lisa Graver. "We have worked closely with the FDA throughout the process, including during the agency's routine inspection in Reykjavik in May and in preparing our detailed response to the PAAL. We believe the outcome of the May inspection reinforces that our facilities meet the highest standards for cGMP drug manufacturing."